Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial

Updated on 3 March 2021


The goal of this research study is to understand whether aging affects vaginal health differently in menopausal women living with and without HIV and whether vaginal estradiol improves symptoms of vaginal atrophy in menopausal women living with HIV. 


The first goal of this two-part research study is to understand whether aging affects vaginal health differently in menopausal women living with and without HIV. We want to determine if having HIV is associated with accelerated vaginal aging including earlier changes in the amount and types of vaginal bacteria and inflammation.

Some menopausal women develop a condition known as vaginal atrophy, which causes uncomfortable symptoms such as irritation, pain with sex, dryness and itching. The second part of this study it to determine whether treatment with vaginal estradiol improves these vaginal symptoms and measures of vaginal health in menopausal women living with HIV.

We will study whether menopausal women with HIV have improvement in vaginal atrophy symptoms and aging associated changes in the vagina (bacteria, inflammation) after using a vaginal estradiol tablet (Vagifem® 10 μg) for 12 weeks.

Participants in this part of the study will be randomly assigned to receive treatment with Vagifem or no treatment. An estradiol tablet placed inside the vagina may prevent or delay the aging process, lead to fewer changes in the types of bacteria present in the vagina, improve vaginal atrophy symptoms and ultimately keep the vagina healthier for a longer period of time.

This is especially important for women with HIV as they are living longer, healthier, sexually active lives because the virus is controlled with medication. Vagifem is safe, effective, and FDA approved for the treatment of symptomatic vaginal atrophy.

Procedures: Participation in both parts of the study involves answering questions about your medical and sexual history, surveys, blood draws, pelvic exam, vaginal biopsies, and vaginal swabs. Participation in Part 2 also involves using an estradiol vaginal tablet for 12 weeks.

Compensation: Participants will be compensated commensurate with the parts in which they enroll. Participants who only complete Part 1 will be reimbursed $125. Participants who only complete Part 2 will be reimbursed $250. Participants who complete all study visits (Part 1 and Part 2) will be reimbursed $300.

Condition Aging, HIV, Women's Health, Menopause, Vaginitis, Vaginal Atrophy, HIV/AIDS, HIV Infection
Clinical Study IdentifierTX253155
Last Modified on3 March 2021


Yes No Not Sure

Inclusion Criteria

Between the ages of 45 and 70
Menopausal, defined as having no periods in the last 12 months
Living with or without HIV
With or without vaginal atrophy symptoms

Exclusion Criteria

You do not qualify to take part in either part of the study if you have any of the following
Unexplained or unevaluated abnormal genital bleeding
Current or suspected pregnancy
If < age 55, had a hysterectomy and has at least one ovary
Pelvic or vaginal surgery in the prior 60 days
Used systemic reproductive hormones in the last 2 months
Used antibiotics in the last 30 days
Used immunosuppressive medications in the prior 60 days including biologics, chemotherapeutics or post-transplant immunosuppressive medications
Used any vaginal or vulvar preparations in the last month
Current active vaginal infection diagnosed at study entry
Any serious disease or condition that may interfere with study compliance
You do not qualify for Part 2 of the study (Clinical Trial) if you have any of the following additional conditions
Current or previous history of breast cancer or estrogen-dependent cancer (e.g. ovarian, endometrial)
Current or previous history of deep vein thrombosis or pulmonary embolism
Current or previous history of myocardial infarction or stroke
Known clotting disorder including Protein C, Protein S and antithrombin deficiency, Factor V Leiden or prothrombin mutations
Known severe liver disease including cirrhosis or active Hepatitis B
Known allergic reaction to Vagifem (estradiol vaginal tablet)
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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